Neuroprotection Bundles For Comatose Survivors Following Cardiac Arrest (LAPTOPS)

Central South University

Status: Enrolling

Conditions: Post-cardiac Arrest Care; Cardiac Arrest

Treatments: Other: Usual Care; Other: Goal-directed care bundle for neuroprotection

Study type: Interventional

Funder types: Other

Identifiers

NCT06992843

2024121757

Details and patient eligibility

About

The investigators designed LAPTOPS to determine the effectiveness of a goal-directed neuroprotection bundles of active management including body temperature,PaCO2,PaO2,position,Blood glucose ,blood sodium,Blood pressure and Lactate vs. usual care in adult post-cardiac arrest care.

LAPTOPS is a large-scale pragmatic clinical trial to provide reliable evidence over the effectiveness of a widely applicable goal-directed care bundle in acute phase of adult post-cardiac arrest care.

Enrollment: 1,008 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years and < 80 years
• Patients of in-hospital or out-of-hospital cardiac arrest who have returned -spontaneous circulation (ROSC) after cardiopulmonary resuscitation and do not require CPR for more than 20 minutes;
• Patients who are unconscious after ROSC, defined as FOUR motor response score < 4 points or GSC ≤ 8 points;
• Family members or legal representatives signed informed consent.

Exclusion criteria

• Unwitnessed cardiac arrest, estimated time from cardiac arrest to start of CPR > 30 minutes;
• Time from cardiac arrest to ROSC > 60 minutes;
• Patients who woke up immediately after ROSC by CPR;
• End-stage diseases;
• Cardiac arrest considered to be caused by neurological diseases;
• The patient was in a vegetative state before cardiac arrest;
• The interval from the onset of cardiac arrest to enrollment is >72 hours .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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1,008 participants in 2 patient groups

Goal-directed care bundle for neuroprotection

Other group

Description:

Management policy to receive a goal-directed care bundle that involves the rapid correction (\<24 hour) of physiological variables as soon as the abnormality is recognised and for the control to be maintained in patients for 72h or hospital discharge (or death, if sooner)

Treatment:

Other: Goal-directed care bundle for neuroprotection

Usual care group

Other group

Description:

Patients receive the usual management based on local guidelines and hospital's individual policy.

Treatment:

Other: Usual Care